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FDA 510(k)

125I DIGOXIN RADIOIMMUNOASSAY KIT

K-Number: K821811 · 1982-07-02

ApplicantCambridge Medical Technology
Decision Date1982-07-02
Product CodeDPB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

125I DIGOXIN RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Medical Technology. It received FDA 510(k) clearance on 1982-07-02 under 510(k) number K821811. The device is classified under product code DPB. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 125I DIGOXIN RADIOIMMUNOASSAY KIT?

125I DIGOXIN RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1982-07-02. The listed applicant is Cambridge Medical Technology. The 510(k) number is K821811.

When did 125I DIGOXIN RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

125I DIGOXIN RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1982-07-02, under 510(k) number K821811.

Who is the listed applicant for 125I DIGOXIN RADIOIMMUNOASSAY KIT?

The FDA 510(k) record lists Cambridge Medical Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 125I DIGOXIN RADIOIMMUNOASSAY KIT?

The FDA product code for 125I DIGOXIN RADIOIMMUNOASSAY KIT is DPB.

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Other records listing Cambridge Medical Technology as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K890837RIA-GNOST INSULINK890697RIA-GNOST FERRITINK890836RIA-GNOST PROGESTERONEK873737NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAYK870573T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KITK862871RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL

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Related Devices (Code: DPB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K853021OPTIMATE DIGOXIN TESTMiles Laboratories, Inc.K823014DIGOXIN KITPcl-Ria, Inc.K820274DIGOXIN RADIOIMMUNOASSAYAmerican Diagnostic Corp.K792153DIGOXIN RADIOIMMUNOASSAY SYSTEMRadioimmunoassay, Inc.K790602RIA, DIGNXIN-125-IEndocrine-Metabolic CenterK790540RIA TEST KIT, CENTRIA DIGOXINVentrex Laboratories, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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